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Is mandatory the use of the docuBridge explorer (document management system) ?

  • 1.  Is mandatory the use of the docuBridge explorer (document management system) ?

    Posted 04-Feb-2024 11:19

    Hi to all,

    I have a question regarding docuBridge or any other eCTD publishing system for United States (FDA) applications.

    Can anyone tell me if the use of the docuBridge explorer (document management system) is mandatory before uploading the documents to the sequence in the docuBridge workbench ?

    There is the option to upload the documents directly to the sequence (in the docuBridge workbench) from the windows explorer, and it is easier and faster than passing through the docuBridge explorer. It is the sequence of the docuBridge workbench that is submitted to the FDA.

    I am not sure if this could be a requirement of the US FDA  21 CFR part 11.

    Thanks for your comments.



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    Lorena Pinzon
    QC, Canada
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